Validation & Compliance Engineer
| Job ID | REQ-058077 |
| Location | Schachen, Entlebuch District, Canton of Lucerne |
| Job Type | Regular |
PerkinElmer's OneSource team is looking for aValidation & Compliance Engineerto join the team on the Customer site (MSD) in Schachen.
More information about PerkinElmer and our business : PerkinElmer | Science with Purpose
More information about our OneSource services: OneSource Laboratory Solutions | PerkinElmer
Hybrid working model
Responsibilities:
Document Review & Approval / Asset Release
Reviews and approves documents as part of calibration, maintenance, and repair work
Collaborate closely with internal and external Calibration & Maintenance Engineers, to close eventual GDocP gaps in provided documentation
Releases assets after successful completion of calibration, maintenance, and repair work
Processes Changes, deviations, and CAPA related with calibration and maintenance
Contributes to changes and investigations as a member of cross-functional teams
Data Management / Administrative Release
Adds, updates, reviews, and releases asset records in the customer calibration/maintenance databases (CCMS/CMMS)
Reviews, approves, and performs administrative release of successful calibration and maintenance entries in Customer CCMS/CMMS systems
Requirements
3 to 5 years of relevant experience in a (Bio-)Pharma company in quality, validation or compliance roles
Expert in CCMS/CMMS
Operator process specialist experience
Bachelor’s degree in a Life Sciences or Quality/Compliance discipline or equivalent experience preferred.
Knowledge of cGMP and validation regulations and requirements
Knowledge of GMP, GLP, GDocP, pharmacopeia and regulatory requirements preferred.
Developed Customer service mindset
Be passionate in attention to detail and tech aspects
Strong written and verbal communication skills in English, German language knowledge will be beneficial.
Ability to work both independently and as a team member, adapt to changing environment
Following customer SOPs and regulatory guidelines FDA, EU & SwissMedic
Join our Team!
We are strongly committed to the development of your career and giving you opportunities to learn and grow.
We make a difference for you while you make a difference in the world!